Borderline Personality Disorder Clinical Trial
— BPDCONFLICTOfficial title:
Analysis of Personal Constructs in Borderline Personality Disorder and Its Relation With Severity and Therapeutic Outcome
NCT number | NCT04498104 |
Other study ID # | UBipcsBPD1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2, 2019 |
Est. completion date | March 1, 2022 |
Verified date | May 2022 |
Source | University of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Borderline personality disorder (BPD) is a severe psychological condition characterized by emotional, interpersonal and self-image instability in addition to impulsive behaviour. Although there have been several explanatory models and psychotherapy approaches that have been designed to comprehend and intervene on BPD, most seem not to recognize idiosyncratic cognitive conflict as an important feature on this disorder. Adding personal dilemmas, such as those conceptualized in personal construct theory, as a key element to BPD's explanatory model could provide a better picture to understand this disorder and possibly to enhance effectiveness of current psychotherapy approaches. Despite the fact that constructivist explanatory models have been used and tested in several clinical populations, there is little work done studying the relevance of inner conflicts in BPD. According to the prototypical symptomatology manifested by these patients, psychological instability can be assumed as a transversal feature present in this disorder; therefore, a larger amount of cognitive conflict can be expected in BPD patients. Method and Analysis: In order to test this assumption, this study aims to examine the characteristics of the interpersonal cognitive system of patients diagnosed with BPD and note their potential differences with the general population using the repertory grid technique, a complex assessment tool derived from personal construct theory. Statistical analyses will be performed to examine whether the clinical sample tends to present with more cases and with higher number of cognitive conflicts than the control group. Likewise, the association between cognitive conflict and symptom severity will be explored. Results will be a first step to determine if cognitive conflicts have an important role in the explanation of BPD. This will also help to value the convenience to further investigate the efficacy of conflict resolution psychotherapy interventions with these patients. This research work is undertaken in the context of a funded predoctoral research program.
Status | Completed |
Enrollment | 156 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | INCLUSION CRITERIA - Aged between 18 and 60 years old. - Having been diagnosed with BPD by a well-trained professional according to DSM-5 criteria. EXCLUSION CRITERIA - Having been diagnosed with bipolar disorder, psychotic disorder, prevalent continued and active substance abuse, disabling physical illness, organic cerebral dysfunctions or mental developmental severe difficulties. - Not able to communicate either in Spanish or Catalan. - Presence of other comorbid conditions such as other personality disorders, anxiety disorders, eating disorders, depression or non-disabling physical illness, will not be an exclusion motive, but will be recorded for statistical control purposes. |
Country | Name | City | State |
---|---|---|---|
Spain | CSMA Bennito Menni - (Germanes Hospitalaries) | Barcelona | |
Spain | ITA - especialistas en salud mental | Barcelona | |
Spain | ITLimit | Sant Cugat Del Vallès |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona |
Spain,
Feixas G, Bados A, García-Grau E, Paz C, Montesano A, Compañ V, Salla M, Aguilera M, Trujillo A, Cañete J, Medeiros-Ferreira L, Soriano J, Ibarra M, Medina JC, Ortíz E, Lana F. A DILEMMA-FOCUSED INTERVENTION FOR DEPRESSION: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL WITH A 3-MONTH FOLLOW-UP. Depress Anxiety. 2016 Sep;33(9):862-9. doi: 10.1002/da.22510. Epub 2016 Apr 22. — View Citation
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Feixas G, Paz C, García-Grau E, Montesano A, Medina JC, Bados A, Trujillo A, Ortíz E, Compañ V, Salla M, Aguilera M, Guasch V, Codina J, Winter DA. One-year follow-up of a randomized trial with a dilemma-focused intervention for depression: Exploring an alternative to problem-oriented strategies. PLoS One. 2018 Dec 13;13(12):e0208245. doi: 10.1371/journal.pone.0208245. eCollection 2018. — View Citation
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Feixas G, Saúl LA. The Multi-Center Dilemma Project: an investigation on the role of cognitive conflicts in health. Span J Psychol. 2004 May;7(1):69-78. — View Citation
Montesano A, López-González MA, Saúl LA, Feixas G. A review of cognitive conflicts research: a meta-analytic study of prevalence and relation to symptoms. Neuropsychiatr Dis Treat. 2015 Dec 4;11:2997-3006. doi: 10.2147/NDT.S91861. eCollection 2015. Review. — View Citation
Paz C, Montesano A, Winter D, Feixas G. Cognitive conflict resolution during psychotherapy: Its impact on depressive symptoms and psychological distress. Psychother Res. 2019 Jan;29(1):45-57. doi: 10.1080/10503307.2017.1405172. Epub 2017 Nov 26. — View Citation
Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implicative dilemma | The repertory grid technique (RGT) is a personalized assessment procedure using a structured interview designed to make explicit the personal constructs (bipolar dimensions of subjective meaning) used to interpret and organize reality. An implicative dilemma can be identified when an individual does not perform a desired change due to the negative implications involved for their desired identity. The RGT can detect personal constructs in which the current perception of the self is similar to the ideal self (congruent constructs) and the constructs in which the subject's self-perception is contrary to their ideal construction (discrepant construct). A statistical analysis of the RGT reveals when a potential pole shift of a discrepant construct involves the pole shift of a congruent construct due to an existing association between the two constructs. Implicative dilemmas may cause dissatisfaction and psychological discomfort. | Through study completion, an average of 2 years. | |
Primary | Dilemmatic construct | Dilemmatic constructs can be identified when an individual is not sure how would they like to be in a certain identity aspect. This type of cognitive conflict can be assessed and analyzed with the RGT in order to identify self-construction domains in which the person may find it difficult to choose how to ideally be. Indecision in regard to identity can add psychological distress to those who experience it. | Through study completion, an average of 2 years. | |
Secondary | Diagnostic Interview for Borderlines - Revised (DIB-R) | It is a structured interview that helps to identify the potential presence of BPD by assessing 22 common statements for BPD patients. It explores aspects related to affectivity, cognition, impulsivity patterns and interpersonal relationships. The test provides an overall score from 0 to 10 that determines presence or absence of BPD (6 or higher indicates presence). | Through study completion, an average of 2 years. | |
Secondary | Structured Clinical Interview for DSM-IV-II (SCID-II) | It is a structured assessment interview aimed to identify the potential presence or absence of the personality disorders defined by the DSM-IV criteria. After completion, results show how many diagnostic criteria are met by the interviewee for each of the 13 personality disorder assesed. When evaluating BPD, scores can go from 0 to 9 (5 or higher indicates presence). | Through study completion, an average of 2 years. | |
Secondary | Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) | It is a self-report questionnaire formed by 34 items (18 in the reduced version) that aims to assess the clinical state of the person in the following four dimensions: subjective well-being, problem/symptoms, general functioning and risk. All scales and an overall measure are computed in order to obtain scores that rank from 0 to 4 (higher scores indicates worse outcome). | Through study completion, an average of 2 years. | |
Secondary | Depression Anxiety Stress Scales (DASS-21) | It is a questionnaire created to quickly evaluate levels of depression, anxiety and stress. Respondents must score in a scale from 0 to 3 to describe the intensity or frequency they experienced about 21 different clinical symptoms during the previous week. Punctuations oscillate between 0 and 63 (higher scores indicates worse outcome). | Through study completion, an average of 2 years. |
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